An Assessment of the Absolute and Relative Bioavailability of Subcutaneous Doses of LY3074828 When Coadministered With LY9999QS to Healthy Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Pharmacokinetics (PK): Area Under the Concentration versus Time Curve (AUC) of LY3074828
研究概览
简要总结
The purpose of this study is to look at the amount of the study drug, LY3074828, that gets into the blood stream and how long it takes the body to get rid of LY3074828 when given together with LY9999QS compared to LY3074828 alone. The tolerability of the different formulations will also be evaluated and information about any side effects experienced will be collected.
Screening is required within 28 days prior to the start of the study. For each participant the total duration of the clinical trial will be approximately 13 weeks, not including screening.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
盲法说明
Open
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Have venous access sufficient to allow for blood sampling and administration of investigational product
- •Have clinical laboratory test results within normal reference range for the investigative site, or results with acceptable deviations that are judged to be not clinically significant by the investigator
排除标准
- •Must not have an average weekly alcohol intake that exceeds 21 units/week (males) and 14 units/week (females)
- •Must not show evidence of active or latent tuberculosis (TB)
- •Must not have received live vaccine(s) (including attenuated live vaccines and those administered intranasally) within 1 month of screening, or intend to during the study
- •Must not be immunocompromised
- •Must not have known hypersensitivity to hyaluronidases
- •Must not have received treatment with biologic agents (e.g. monoclonal antibodies, including marketed drugs) within 3 months or 5 half-lives (whichever is longer) prior to dosing
- •Must not have significant allergies to humanised monoclonal antibodies
- •Must not have clinically significant multiple or severe drug allergies, or intolerance to topical corticosteroids, or sever post treatment hypersensitivity reactions
- •Must not have had lymphoma, leukemia, or any malignancy within the past 5 years except for basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years
- •Must not have had breast cancer within the past 10 years
研究组 & 干预措施
LY900021 - Treatment 4
Single SC dose of LY900021 (LY3074828 coadministered with LY9999QS)
干预措施: LY900021 (Biological)
LY900021 - Treatment 3
Single SC dose of LY900021 (LY3074828 coadministered with LY9999QS)
干预措施: LY900021 (Biological)
LY900021 - Treatment 2
Single subcutaneous (SC) dose of LY900021 (LY3074828 coadministered with LY9999QS)
干预措施: LY900021 (Biological)
LY3074828 - Treatment 1
Single intravenous (IV) dose of LY3074828
干预措施: LY3074828 (Biological)
结局指标
主要结局
Pharmacokinetics (PK): Area Under the Concentration versus Time Curve (AUC) of LY3074828
时间窗: Baseline through Day 85
PK: AUC of LY3074828
次要结局
未报告次要终点